Generally speaking, FDA cannot compel a mandatory recall, except in very limited circumstances as authorized by statute, none of which apply to drugs (see here at § 7-5-3). FDA can order a recall when the Agency:finds there exists a reasonable probability that a device intended for human use would cause serious, adverse health consequences or death (21 U.S.C. § 360h(e)(1)); determines that a batch, lot, or other quantity of a biological product presents an imminent or substantial hazard to the public health (42 U.S.C. § 262(d)(1)); determines that an adulterated or misbranded infant formula presents a risk to human health (21 U.S.C. § 350a(e); see also 21 C.F.R. § 107.200);finds there is a reasonable probability that a tobacco product contains a manufacturing or other defect not ordinarily contained in tobacco products on the market that would cause serious, adverse health consequences or death (21 U.S.C. § 387h(c)(1)); ordetermines there is a reasonable probability that an article of food (other than infant formula) is adulterated or misbranded and the use of or exposure to such article will cause serious adverse health consequences or death to humans or animals (21 U.S.C. § 350l(a));Finally, FDA has the discretion to compel a mandatory recall when it finds that a human cell, tissue, or cellular and tissue-based product is a source of dangerous infection to humans, or does not provide adequate protections against the risks of communicable disease transmission.Recalls, in situations other than those described above, are voluntary actions by a company expected to conform to FDA policy set forth in its regulations.